MAUDE Adverse Event Report: MEDTRONIC/COVIDIEN FORMERLY MICRO THERAPEUTICS, INC. DBA EV PIPELINE EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED 350 18

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2016

Event Type  malfunction  

Event Description

The stent became detached in the delivery catheter.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC/COVIDIEN FORMERLY MICRO THERAPEUTICS, INC. DBA EV; 9775 toledo way; irvine CA 92618
• MDR Report Key: 6099823
• MDR Text Key: 59789349
• Report Number: 6099823
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/01/2019
• Device Model Number: PED 350 18
• Device Lot Number: A249773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/12/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UNKNOWN.